Phytonadione Tablet
NDC Package 0574-1850-30

11-digit billing NDC: 00574185030
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Phytonadione tablets is phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.•anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;•hypoprothrombinemia secondary to antibacterial therapy;•hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;•Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. This formulation utilizes a tablet delivery system. Marketed by Padagis Us Llc, this product is identified by NDC 0574-1850 and is authorized under FDA application ANDA220454.

Identification & Billing

NDC Package Code
0574-1850-30
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
Product Code
0574-1850
11-Digit Billing Format
00574185030

Clinical Specifications

Proprietary Name
Phytonadione
Non-Proprietary Name
Phytonadione
Substance Name
Phytonadione
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHYTONADIONE 5 mg/1
Pharmacologic Class
Usage Information
Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.•anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;•hypoprothrombinemia secondary to antibacterial therapy;•hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;•Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

Regulatory & Marketing

Labeler Name
Padagis Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA220454
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0574-1850-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet in 1 bottle of Phytonadione, a human prescription drug labeled by Padagis Us Llc. This tablet is formulated for oral use and contains phytonadione as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Us Llc on October 28, 2026. The current certification is valid through December 31, 2027.

How is this Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574185030. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0574-1850-30
11-Digit CMS (5-4-2)
00574-1850-30

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.